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Retigabine

Phase 2

Postherpetic Neuralgia | Small molecule | Pain |Bausch Health Companies Inc.|Last Updated: May 8, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment187

FDA Designations

No designations recorded

Clinical trial landscape

Retigabine · 1 trial · 1 indication

Phase 2 1
NCT00612105Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)Postherpetic Neuralgia
COMPLETED187 Analytics
PHASE2COMPLETED
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Postherpetic NeuralgiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.
Baseline and Week 4 (Maintenance Phase-MP)

Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.

Secondary Endpoints

Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment
Baseline and Weeks 2 and 4 (Maintenance Phase - MP)
Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)
Weeks 1, 2, 3, and 4 Maintenance Phase
Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)
Baseline and Weeks 1, 2, 3, and 4 (MP)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRetigabine
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
RetigabineDRUG150mg/day up to 900mg/day
PlaceboDRUGdaily
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: * Ability to provide informed consent * Male or female subjects * 18-85 years of age * PHN for more than 6 months after the healing of herpes zoster skin rash * Has a pain score at screening and randomization that qualifies Exclusion Criteria: * Other significant pain that may...

Countries:United StatesSouth Africa
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Frequently asked questions about Retigabine

What is Retigabine used for?

Retigabine is an investigational small molecule being studied for the treatment of postherpetic neuralgia, a type of nerve pain that occurs after a shingles infection. It is currently in Phase 2 clinical development for this condition.

Who makes Retigabine?

Retigabine is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with postherpetic neuralgia.

What phase is Retigabine in?

Retigabine is in Phase 2 clinical development for postherpetic neuralgia. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is Retigabine in?

Retigabine has been studied in one completed Phase 2 clinical trial, NCT00612105, which evaluated its safety and efficacy compared to placebo in 187 patients with postherpetic neuralgia. The trial was conducted in the United States and South Africa.

Is Retigabine the same as ezogabine?

Retigabine is also known as ezogabine. The drug has been studied under both names in clinical trials for postherpetic neuralgia and other pain conditions.